UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004250
Receipt number R000005104
Scientific Title Multicenter Study of Efficacy and Safety of recombinant thrombomodulin alfa for Obstetric disseminated intravascular coagulation (DIC)
Date of disclosure of the study information 2010/09/27
Last modified on 2013/03/22 16:43:48

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Basic information

Public title

Multicenter Study of Efficacy and Safety of recombinant thrombomodulin alfa for Obstetric disseminated intravascular coagulation (DIC)

Acronym

Multicenter Study of Efficacy and Safety of rTM for Obstetric DIC

Scientific Title

Multicenter Study of Efficacy and Safety of recombinant thrombomodulin alfa for Obstetric disseminated intravascular coagulation (DIC)

Scientific Title:Acronym

Multicenter Study of Efficacy and Safety of rTM for Obstetric DIC

Region

Japan


Condition

Condition

Disseminated intravascular coagulation (DIC)

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of rTM in patients with obstetric DIC.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Course of obstetric DIC score

Key secondary outcomes

Course of DIC score; Course of clinical symptom; Course of blood clotting test findings; Outcome of subjects; Transfusion; Blood loss; Adverse events; Adverse drug reaction


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1.Patients diagnosed clinically as DIC (the obstetrical DIC score reaches 8 points or more).
2.Postpartum or intrauterine fetal resuscitation.
3.Written informed consent of participation.

Key exclusion criteria

1.Patients showing intracranial, pulmonary or gastrointestinal hemorrhage.
2.Patients with a history of hypersensitivity to rTM.
3.Pregnant women, nursing mothers or possibly pregnant women (Fetal viability).
4.Hematopoetic malignancy.
5.Other patients judged to be inappropriate at the discretion of investigators.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masao Nakabayashi

Organization

Maternal and Child Health Center Aiiku Hospital

Division name

Department of Obstetrics and Gynecology

Zip code


Address

5-6-8 Minami-Azabu, Minato-Ku, Tokyo 106-8580, Japan

TEL

03-3473-8321

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Maternal and Child Health Center Aiiku Hospital

Division name

Department of Obstetrics and Gynecology

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Maternal and Child Health Center Aiiku Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

順天堂大学医学部附属順天堂医院(東京都)
埼玉医科大学総合医療センター(埼玉県)
県西部浜松医療センター(静岡県)
宮崎大学医学部附属病院(宮崎県)


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 27 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 09 Month 16 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2013 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective observational study


Management information

Registered date

2010 Year 09 Month 22 Day

Last modified on

2013 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005104


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name